Mario Marazziti, President of the Italian XII Social Affairs Commission, discusses new legislation relating to clinical risk, the effects of the 2014 Pact for Health, and the efficiency of Italian healthcare in general.

You were recently highly instrumental in the passing of new legislation relating to clinical risk. Could you please explain why you regard this as an important milestone in Italian healthcare and what exactly this bill seeks to address?

For the first time in two decades, we now have an organic law covering clinical risk. Over the years, we’ve witnessed a sharp rise in litigation against healthcare professionals and thus there is an increased need for doctors, nurses and those in the managerial categories to start protecting themselves legally with regard to their individual professional conduct. The reality is that instances of malpractice that could be properly categorized as criminal activity are exceptionally rare. Only around two percent of these sorts of trials are judged to involve a penal aspect. Despite this, vast amounts of money, time, and resources are often expended on lengthy litigation processes and compensation claims that, even then, can fail to apportion clear responsibility for actions that have taken place. The end result is, all too often, dissatisfied claimants, disgruntled healthcare professionals, confused citizens and inefficient deployment of scarce resources.

The new legislation seeks to rectify this by delivering much greater clarity, swifter adjudication timeframes and a unified protection system that obliges healthcare professionals to be properly insured. The concept is about putting in place a balanced and fair framework that delivers better outcomes all round without overly privileging any single group of stakeholders. By streamlining, harmonizing and simplifying the way that we deal with these sorts of issues, we can channel efforts back to what is ultimately most important: patient welfare and citizen satisfaction. Barely six months ago, when I was appointed president of the social affairs commission I resolved to address the matter of clinical risk through the passage of practically applicable, fit-for-purpose legislation. I am proud to be able to announce that we have accomplished this objective.

You speak of the scope for rationalizing the Italian healthcare regime and injecting efficiency into the way that the system operates. What further improvements can you envisage?

Rationalizing public health partly entails making the system more just. It is important that we rediscover the values of ‘universality’ and ‘justice’ and enshrine them in any reforms that we enact. Italian healthcare is distinctive in the level of autonomy afforded to the regions. Having 21 different healthcare systems within the same country certainly brings its advantages, but also has obvious drawbacks.

On the one hand, public health policy formation takes place much closer to the end-patient and thus local concerns can be properly incorporated. On the other hand, the fragmentation inherent to such a regionalized set-up tends to adversely impact the equality of treatment received. It creates a postcode lottery in which there are considerable discrepancies in quality of treatment according to the location in which healthcare services are being delivered. There are many statistics to back this up. Data that we have captured demonstrates that there is a 10 percent chance of receiving inappropriate treatment in the Aosta Valley and 20 percent chance in Lombardy and South Tyrol, but then the probability rises as high as 30 percent for regions like Lazio, Molise, Abruzzo, Sardinia, and Calabria. This degree of divergence in the services that our citizens are receiving is unacceptable for a country that believes itself to be fair, just and egalitarian.

Beyond this, there are a great many areas where we could act in a better, more enlightened fashion. Surveys conducted across the medical class can be very useful in shining a spotlight on potential resource efficiency gains. 82.8 percent of physicians admit to prescribing diagnostic-therapeutic courses of action above and beyond the strictly necessary. For example, 70 percent admit to sending patients to hospitals for treatments of pathological conditions that, with hindsight, could quite easily have been handled just as well by an ambulatory, outpatient day-clinic. 60 percent of physicians meanwhile confess to being overly enthusiastic to prescribe clinical tests, while 58 percent admit to having transferred patients for consultations with specialists, when they might themselves have capably conducted the diagnosis. In each of these instances, there are very clear opportunities for improvement and potential efficiencies to be realized.

In July 2014, a new Pact for Health was signed to provide a basis for healthcare spending throughout the country up to 2016. At the start of the pact’s final year, how would you rate its success in portraying healthcare and pharmaceutical spending as not only a cost, but also as an investment?

Increasing health expenditure, in itself, is not a sustainable solution in the long term and the Pact for Health recognizes this by exploring alternative avenues. Italy, like many mature Western European economies, is afflicted by an ageing population, which increases the pressure on the public health system year on year. By way of perspective, the Italian National Institute of Statistics (ISTAT) has forecast a high rise in the average age of the Italian residents, increasing from 43.5 years of age to 49.8 years by 2059, while the proportion of the elderly in the population is predicted to reach 30.9 percent over the same time period. Technically this means that we should be increasing our health expenditure by 7 to 10 percent per annum to maintain overall standards of quality, merely to cater to the additional pharmaceutical needs of these new cohorts of elderly people. Given the state of the national finances, however, this is clearly not affordable. We therefore have to adopt much more creative approaches to realizing our agreed objective of effective, universalistic, sustainable healthcare that can deliver a maximal not minimal level of quality for many years to come.

Approaching healthcare as an opportunity to invest in the nation’s future rather than a drag on the economy is tremendously important. We must not underestimate the sheer potential of the pharmaceutical sector as an incredible tool for growth. During the recent period of economic instability and crisis, this was a sector that proved able, nonetheless, to invest in innovation to the tune of some EUR 2.5 billion in research and to create jobs for some 6,000 in R&D alone. When you calculate the sheer productivity per person of pharmaceutical professionals and the contribution that the drugs trade makes to our export ratios, you will find that the figures are immensely encouraging.

The pharma sector is a critical pillar of the national economy featuring a cast of big-brand multinationals, local companies and SMEs making the industry a great platform for Italy to interact with the world economy. One only need look at the number of multinationals positioning their regional hubs and headquarters in our country or the scientific districts and centers of excellency popping up locally that can compete internationally. Also let’s not forget that Italy has something distinctive to offer to the pharmaceuticals world given our strong track record for research and artisan heritage.

In the past, too many governments have viewed the pharma sector as a burden and drain on the public purse. Instead we need to return to a concept of integrated healthcare where social services, healthcare provision and drug expenditure are all treated as part of the same continuum. Through careful, targeted investment in areas like diagnostics, preventative care and high-impact innovations we can ensure that a greater portion of the population remain in health. Meanwhile it’s worth remembering that healthy people are more likely to be in work, thus be contributing to the national economy meaning that there can potentially be a very real return on the initial investment. It’s time to appreciate the windfall to be derived from keeping citizens healthy and putting them back to work. The Pact for Health offers a good start for enshrining this type of thinking and for ensuring that we can achieve a better result with the same resources.

What existing resources can be better mobilized?

Smart healthcare policy is not just about building large hospital complexes and installing fancy technology. If we can restore the linkages between health prevision and social welfare then we can transform the system model from total institutionalized healthcare to something more versatile and diversified. One way of better deploying the resources at our disposal would be by coopting the strong familial and social networks that Italian culture is renowned for and by pioneering patient-centric concepts such as ‘home care’ where the patient is treated effectively at source and with less expense. Territorialized care can trigger a whole host of co-benefits while simultaneously offering a far greater value for money. Imagine a situation where citizens only visit the hospitals for treatment of grave and acute illnesses and chronic diseases are instead dealt with professionally either in the patient’s own home or in local outpatient clinics and similar ambulatory structures. Imagine a holistic system where families and local communities are coopted as caregivers and the patient himself is empowered to be more autonomous in his treatment.

Obviously this entails changing mindsets and to realize this vision we will have to mobilize a coalition of actors encompassing the policy makers, physicians, opinion leaders, patients and crucially the media. Resistance to change is a common phenomenon and we will be reliant on the media to articulate the benefits. It would be important to win people over who might be fearful at the thought of the clinic round the corner closing down until they discover the virtues of home service. There would be logistical challenges along the way as well. In some respects, creating and operating a big centralized structure is simpler than coordinating a network that goes directly into the individual homes of 20,000 elderly people.

That said, we can take a lot of heart from individual pilot projects that have proved immensely successful. One example would be the excellent work of the community of Sant’Egidio, a charitable movement that has been pioneering new models of public health through its ‘Drug Resource Enhancement against Aids and Malnutrition (DREAM) programme in Africa. This is essentially a light system which endeavors to meet the needs of patients through the holistic approach of mobilizing local social and community networks and deploying micro-health centers spread across rural areas thus reaching out to patients with economic and transportation difficulties. In the aftermath of the 2003 heat wave in Italy, Sant’Egidio rolled out another acclaimed program called ‘Viva gli Anziani’ mobilizing solidarity from shopkeepers, physicians, relatives and social workers to ensure the wellbeing and monitoring of thousands of elderly citizens without families who were vulnerable to heatstroke. These are all lessons that we must capture and which can be used to inform future policy and decision making.

How supportive is the incumbent government of such efforts?

The Renzi administration is supportive of anything that is innovative, it is fast in grabbing opportunities, even where there are some risks involved. Right now there is an excellent window of opportunity to build consensus and break down the silos and ceilings that prevent civil society, families, the social welfare sector, patient associations, academia, healthcare providers, pharmaceutical companies, and the media from working together in a joined-up and concerted manner.

One issue that is raised by many of the industry leaders that we have interviewed is the claw-back system for budget overruns in the pharmaceutical industry. As president of the Commission, what is your opinion on the viability of this system?

The claw-back is one way of permitting the national health system and pharmaceutical companies to coexist harmoniously. Maybe there are alternative mechanisms out there that would work better, but the core principle that companies shoulder the responsibility of being part of national health provision is a sound one. As legislators, we appreciate that private industry needs to generate profits and to cover their R&D costs for innovating new drugs, but there is also a social responsibility inherent to participating in the health sphere. They have to play their part in ensuring that the overall system is sustainable, universal, and egalitarian.

What the Italian state apparatus has to guarantee in return is that the rules of the game are stable and that pharma companies know exactly what is expected of them well in advance. I am sympathetic to private enterprises that complain that they cannot formulate proper business strategies because of the frequency with which the legal framework is altered. The good news is that the Renzi administration is fully aware of this concern and stridently committed to ensuring a predictable, reliable and normal system that the business community can both trust and navigate with ease. Private enterprise and government need to collaborate with each other to realize win-win solutions. We are working on this.

Despite the hardships the country has been through, it is still able to provide its citizens with a high standard quality of care. Recently Italy has been named the most efficient healthcare system of any large country in the world by Bloomberg, and third most efficient overall. Do you believe that even in a time of increasingly expensive medicines and shrinking budgets, Italy can retain this tradition of resilience?

Both France and Germany spend more on healthcare than us and yet we are putting to better use the resources that we possess. This is a lesson in itself. We have proven our resilience many times over, but can do even better. Having 21 different variations within the same national health system is holding us back and we need to rectify that by socializing examples of good practice and being courageous in combating mismanagement of resources. We can maintain and surpass current levels of quality so long as we recreate the continuum between social services, civic society, the pharma industry and healthcare providers. We are blessed with excellent human resources, appropriate societal structures and an impressive R&D tradition in the universities. The task at hand will be to exploit latent resources like our much underused, but fine social networks and to get all stakeholders collaborating as a team to make full use of our budgets and surmount any deficiencies in expenditure. I am confident this is well within our grasp as a nation.

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